QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Full Text Full Text (PDF) All Versions of this Article: jpet.105.085712v1 314/3/939    most recent Submit a response Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Services Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Gibson, J. E. Articles by Taylor, D. A. Search for Related Content PubMed PubMed Citation Articles by Gibson, J. E. Articles by Taylor, D. A.

PERSPECTIVES IN PHARMACOLOGY

Can Claims, Misleading Information, and Manufacturing Issues Regarding Dietary Supplements Be Improved in the United States?

The Department of Pharmacology and Toxicology, The Brody School of Medicine at East Carolina University, Greenville, North Carolina

The safety and effectiveness of over-the-counter (OTC) drugs are assessed through the Food and Drug Administration's (FDA's) OTC drug review. Prescription drugs are approved through the rigorous new drug application (NDA) process. In contrast, dietary supplements are regulated as foods, and the FDA must determine that a dietary supplement ingredient poses a "significant or unreasonable risk of illness or injury" instead of requiring the manufacturer to provide safety data. According to the FDA, there are more than 29,000 different dietary supplements available to consumers today. This momentum has its roots in consumer interest in health and self-care and suggests that Americans are searching for alternatives to conventional foods for physical and mental well being. The Committee on the Framework for Evaluating the Safety of Dietary Supplements was formed under the auspices of the Food and Nutrition Board that produced a report entitled Dietary Supplements: A Framework for Evaluating Safety. Categories of specific information identified for use are 1) human data, 2) animal studies, 3) in vitro experiments, and 4) information on related substances. Several factors were identified to guide the FDA in applying the framework. Two of these factors are expressed as follows: 1) "the appropriate scientific standard to be used to overturn this basic assumption of safety is to demonstrate significant or unreasonable risk, not prove that an ingredient is unsafe"; and 2) "approaches taken by diverse organizations and governmental bodies, both within and outside the United States, which evaluate the safety and at times efficacy of dietary supplement ingredients, vary in their relevance to the protection of the American public from risks associated with consumption of dietary supplement ingredients".

Address correspondence to: Dr. James E. Gibson, Department of Pharmacology and Toxicology, The Brody School of Medicine at East Carolina University, 600 Moye Blvd., Greenville, NC 27834. E-mail: gibsonj{at}mail.ecu.edu

This article has been cited by other articles:

				J. Martin, Z. Q. Wang, X. H. Zhang, D. Wachtel, J. Volaufova, D. E. Matthews, and W. T. Cefalu Chromium Picolinate Supplementation Attenuates Body Weight Gain and Increases Insulin Sensitivity in Subjects With Type 2 Diabetes Diabetes Care, August 1, 2006; 29(8): 1826 - 1832. [Abstract] [Full Text] [PDF]